Summaries of health policy coverage from major news organizations

Researchers at the University of California-San Francisco studying experimental breathing techniques violated federal patients' rights guidelines by improperly obtaining consent, according to investigators from the HHS's Office for Human Research Protections, the San Francisco Chronicle reports. An 861-person nationwide study on routine ventilator settings, which ended in 1999, included 105 UCSF patients. The Chronicle reports that study enrollees were "too sick to give consent for themselves," and federal investigators found that "at least in some circumstances" UCSF researchers violated the rights of the patients by improperly receiving consent to enroll them in the study. Among the violations:

UCSF researchers proceeded with the study on emergency room patients who were "too sick to speak or hold a pen," merely requiring the patient to confirm their agreement with a "nodding gesture";

Family members gave consent for patients over the telephone and did not receive anything in writing describing the study or its risks; and

Consent documents given to relatives who gave consent in person did not include the possible risks involved with the study, including breathing difficulties and a "potentially life-threatening jump" in blood sodium levels.

Dr. John Luce, a pulmonary specialist at San Francisco General Hospital who was involved in the research, said UCSF has modified its consent policy in response to the federal inquiry (Tansey, San Francisco Chronicle, 7/28).
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